Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

Completed · Phase 4

Conditions studied: Benign Disease Where Total Hysterectomy is Indicated

In brief

This is a prospective, non-randomized, single arm, multicenter, study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. The study will not modify or influence current surgeon technique. Investigators will perform each procedure using the device in compliance with their standard surgical approach and product labeling. The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled, calibrated, and/or used in accordance with manufacturer design specifications, product instructions and guidelines

Key facts

Study ID

NCT02278640

Run by

Ethicon Endo-Surgery

People needed

40

Starts

2014-10-01

Expected to finish

2015-06-01

Last updated by the study team

2016-08-19

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects satisfying all of the following criteria will be considered the screening population and will be eligible for participation in this study:
• Indicated for elective total laparoscopic hysterectomy
• Age >=40 years and no future desire for fertility

You may not qualify if…

• Subjects with any of the following criteria will be excluded from the study:
• Preoperative exclusion criteria:
• Known or suspected uncontrolled bleeding disorders
• Subjects unlikely to comply with protocol procedures or adhere to the study visit schedule
• Any condition rendering a subject unable to understand the nature, scope, and possible consequences of the study or study procedures
• Any Subject unwilling to sign the study informed consent document
• Any suspected malignancy
• Any Subject of childbearing potential with a positive or serum pregnancy test within 24 hours prior to surgery
• Intra-operative exclusion criteria:
• Any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure

Where it is running

• Florida Hospital Celebration Health — Celebration, Florida, United States
• The Advanced Gynecological Surgery Institute — Schaumburg, Illinois, United States
• Gynaecoloog (aandachtsgebied: endoscopische chirurgie) — Nijmegen, Netherlands
• The Royal Surrey County Hospital NHS Trust — Surrey, United Kingdom

Full record on ClinicalTrials.gov

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